Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency

Phase 2

Suspended

• Conditions: Ocular Surface Disease

• Registration Number: NCT00348114
• Lead Sponsor: Singapore National Eye Centre

Brief Summary

To evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and scarring of the corneal surface.

Detailed Description

The corneal epithelium is under constant cell-turnover,and it has been shown that the limbus is the ultimate source of epithelial renewal. Significant damage to limbal cells causes a disease state called limbal stem cell deficiency(LSCD),characterized by different extents of conjunctival overgrowth onto cornea, vascularization, chronic inflammation, and poor epithelial integrity.

In unilateral LSCD, the damaged corneal surface may be reconstructed using two large segments of healthy limbal tissue (of approximately 6-8mm by 1mm) from the fellow eye in the procedure of conventional limbal transplantation.This may however compromise ocular surface integrity of the healthy eye depending on the amount of donated limbus. In more recent years, it has been possible to "save" limbal tissue by obtaining only a very small limbal biopsy (2mm by 1mm) from the fellow healthy eye which is "expanded" into a viable sheet of limbal cells via laboratory cultivation.This cultivated sheet of cells is transplanted to treat the damaged ocular surface.

This study is a prospective nonrandomized trial which evaluates the efficacy of transplantation of autologous ex-vivo expanded limbal epithelium on intact amniotic membrane for unilateral total limbal stem cell deficiency.

Study Timeline

• Status Verified: 2002-01
• Study Start: 2002-05
• Study Completion: 2006-05
• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-03
• Last Update Submitted: 2006-07-03
• Study First Posted: 2006-07-04
• Last Update Posted: 2006-07-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• unilateral total limbal stem cell deficiency with normal fellow eye, or minimally damaged fellow eye (less than 1/3 limbus affected)

Exclusion Criteria

• systemic disease affecting both eyes such as Stevens-Johnson syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Snellen visual acuity
corneal epithelial integrity and stability

Secondary Outcome Measures

Name	Time	Method
extent of retarding recurrent neovascularisation